Evaluation of SCOUT DS in Subjects With Type 2 Diabetes (TCOYD)
This study has been completed.
Sponsor:
VeraLight, Inc.
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01346033
First received: April 28, 2011
Last updated: December 3, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 28, 2011 | ||||
| Last Updated Date | December 3, 2012 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Validation of SCOUT DS algorithm for detecting known type 2 diabetes [ Time Frame: 1 day ] [ Designated as safety issue: No ] Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes |
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| Original Primary Outcome Measures ICMJE |
Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes [ Time Frame: 1 day ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01346033 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of SCOUT DS in Subjects With Type 2 Diabetes | ||||
| Official Title ICMJE | An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes | ||||
| Brief Summary | The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes. |
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| Detailed Description | Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center |
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| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Those with Type 2 diabetes
All subjects have been diagnosed with type 2 diabetes. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 270 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01346033 | ||||
| Other Study ID Numbers ICMJE | VL-2714 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | VeraLight, Inc. | ||||
| Study Sponsor ICMJE | VeraLight, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | VeraLight, Inc. | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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